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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03609788
Other study ID # 71306642-050.01.04-10/12
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 15, 2018
Est. completion date December 15, 2018

Study information

Verified date December 2018
Source Istanbul Medeniyet University
Contact ferda yilmaz inal
Phone 00905058207650
Email ferdayilmazinal@hotmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The Pain Sensitivity Questionnaire(PSQ) is a self-rating measure for the assessment of pain sensitivity and has been developed by Dr. R. Ruscheweyh in Germany. It consists of 17 items rated from 0, not at all painful to 10, most severe pain imaginable. The validation of the Turkish version of PSQ is needed, in order to measure pain sensitivity among Turkish people.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 15, 2018
Est. primary completion date December 15, 2018
Accepts healthy volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- ASA 1-2

- adult chronic low back pain patients having pain for greater than 3 months

Exclusion Criteria:

- Failed back surgery syndrome,

- Morbid obesity (body mass index, >40),

- Being a non-Turkish speaker,

- Substance abuse disorder,

- Major psychiatric disorder (eg, severe depression, bipolar disorder, Axis II personality disorder, and schizophrenia).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Istanbul Medeniyet University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of pain intensity in Turkish people using The Turkish version of the PSQ Measurement of pain intensity in Turkish people using The Turkish version of the PSQ, consisting of 17 items, describing different daily life situations with a scoring from 0(not painful) to 10 (worst pain imaginable) on a numeric rating scale. A PSQ total score is between 0-10, the higher score, the more patient's pain sensitivity. 1 day
Primary Pain Catastrophizing Scale This scale is used in order to assess the state of mind of patients in pain through a comprehensive evaluation instrument that encompasses the different perspectives on catastrophizing. It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52.24 The higher the score, the more catastrophizing thoughts are present. 1 day
Primary Beck Anxiety Inventory This scale, consisting of 21 items, is a self-report measure of anxiety. Score of 0-21 shows low anxiety. Score of 22-35 shows moderate anxiety. Score of 36 and above shows potentially concerning levels of anxiety. 1 day
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